Health Committee on Feb. 7th, 2007

[Dave Batters, Conservative, Palliser, SK]

Thank you very much.

That's all, Madam Chair.

[The Vice-Chair, Bloc, Christiane Gagnon]

Ms. Brown.

[Bonnie Brown, Liberal, Oakville, ON]

Thank you, Madam Chair.

Welcome to everybody.

Mr. Yeates, it was said in the department's response that you are strengthening Health Canada's post-market surveillance for safety and effectiveness. How many post-market surveillance studies on individual drugs or devices are ongoing at the present moment and how many staff are doing the surveillance and the analysis?

[Neil Yeates]

Thank you for that question.

I don't have a precise number with me in terms of the number of follow-up studies, but we can get that to you.

The number of staff we have in our post-market area will be growing to around 190 next year. So it has grown fairly significantly from the time these audits were done.

[Bonnie Brown, Liberal, Oakville, ON]

Of the 190, how many of those are in Ottawa and how many are in the field?

[Neil Yeates]

They are mostly here in Ottawa. We do have regional adverse drug reaction reporting centres around the country. There are seven of those.

[Bonnie Brown, Liberal, Oakville, ON]

You are now combining the idea of post-market product surveillance with adverse reactions, even though they are separated here. In the presentation, it says one example is strengthening post-market surveillance, and a final example is “more information available to the public about the basis on which decisions are taken, adverse drug reactions and product risks”. But it's essentially all the same people, you're saying.

[Neil Yeates]

The adverse reaction work we do is within our post-market area. Yes, that's part of the continuum.

[Bonnie Brown, Liberal, Oakville, ON]

You said you had 14,000 reports of adverse reactions, and 200,000 others, probably from other countries—

[Neil Yeates]

Yes.

[Bonnie Brown, Liberal, Oakville, ON]

—and research, looking at the Internet and that sort of thing. But you're saying there were 14,000 in Canada.

[Neil Yeates]

Yes.

[Bonnie Brown, Liberal, Oakville, ON]

Okay.

Could you tell me the sources of those? What percentage are alerts coming from the companies that produce the products, as opposed to alerts from citizens and physicians? What percentage of those would be from physicians?

[Neil Yeates]

Sorry, I don't have that breakdown with me, but again, we can get that to you.

[Bonnie Brown, Liberal, Oakville, ON]

It would be interesting to know, because on the adverse reactions—as my colleague Ms. Fry has said—this committee studied that quite seriously. We were somewhat shocked to learn how few of those are coming in from physicians, how few of those are coming in from citizens, and how heavily we're depending on other countries and the companies themselves who produce the products. So we are not sure that is a dispassionate source of this information. It has to be pretty serious before the company is going to squeal on itself.

[Neil Yeates]

The adverse reactions we seek are generally for serious reactions, and as I've noted and as you've noted, we get those within Canada. Yes, the manufacturers are a significant source of those, because they are required to report them. The international data, again, comes from a variety of sources, but it's through our colleague regulators. All told, it's a very large volume of information.

[Bonnie Brown, Liberal, Oakville, ON]

But citizens are not sending in many of these.

[Neil Yeates]

No, but they have the opportunity to do that, and we are looking at means of how we can increase reporting from the entire array of people who have an interest—practitioners, consumers, and so on.

[Bonnie Brown, Liberal, Oakville, ON]

Have you started to advertise the phone number, where citizens can phone that kind of information in, should they feel so motivated? We understood there were people sitting by phones, but nobody out there knew the number.

As Deborah Grey said once at one of these meetings, the reporting mechanism for adverse reactions for the public is “1-800-We-Don't-Care”.

I'm sure we do care, but the fact is, nobody knows where to phone.

[Neil Yeates]

Yes.

We would agree that we need to do more promotion of this. We do have the regional centres, so there's work that's occurring in each region. Outreach is being done. Education is being done with the professions on adverse reporting. This information is available on the website as well.

We do have a lot of hits on that website. As members probably know, we released Canada's Food Guide this week, and we actually had 165,000 hits on the website in 24 hours. The website is a huge source of information. The adverse reporting information is available on the website as well.

[Bonnie Brown, Liberal, Oakville, ON]

Thank you, Madam Chair.

[The Vice-Chair, Bloc, Christiane Gagnon]

Mr. Dykstra.

[Rick Dykstra, Conservative, St. Catharines, ON]

Thank you.

One of the points made, Ms. Fraser, was that the audit team selected a random sample of 154 invoices for claim processing—I'm speaking about chapter 10 now—charged by the contractor from 1999 into 2005, and 22 invoices, evaluated at $5.5 million, had no documentation to support the volume of claims processed. Were 22 invoices just paid without actually verifying that they should be paid or that a service had actually been delivered or a product had been provided?

[Sheila Fraser]

There was no documentation in the files to indicate that the person authorizing payment had established that the services had actually been received.

[Rick Dykstra, Conservative, St. Catharines, ON]

If I understand the process correctly, the signator, the person who would sign off on the receipt, would then send it to the Receiver General for payment.